Heart valve measurement tool

• US 5,489,296 A
• Filed: 12/17/1993
• Issued: 02/06/1996
• Est. Priority Date: 12/17/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Autogenics Co.
• Inventors: Love, Jack W., Love, Charles S.
• Primary Examiner(s): RIMELL, SAMUEL G
• Application Number:
  US08/169,618
• Time in Patent Office: 781 Days
• Field of Search: 128/774, 623/2, 623/66, 623/900, 623/901, 137/515.7
• US Class Current: 623/2.11
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

The present invention provides a heart valve measurement tool in the form of an obturator. The obturator is specifically configured to measure the size of the annulus of the heart to be fitted with a prosthetic heart valve. A plurality of obturators of varying sizes are utilized to determine the appropriate valve size.

Claims

1. An obturator for measuring the size of a valve annulus in a human heart prior to the implantation of a bioprosthetic replacement heart valve having a base portion with inflow, inner and outer diameters into said heart, said obturator threadably engageable with a handle for insertion into the annulus of a human heart, said obturator comprising:

a first section having a generally cylindrical shape and a threaded hole drilled through its center;

a second section having the shape of a conical frustum;

a third section having the shape of an inverted conical frustum; and

a fourth section having a generally cylindrical shape.

2. The obturator of claim 1, wherein said obturator is comprised of a plastic, biocompatible material.

3. The obturator of claim 2, wherein said material is Polysulfone.

4. The obturator of claim 1, wherein the configuration of said first, second and third sections of said obturator resembles a prosthetic replacement heart valve.

5. A method for measuring the size of an annulus of a patient'"'"'s heart prior to the implantation of a bioprosthetic heart valve, said valve including a base portion having inflow, inner, and outer diameters, said method comprising the steps of:

providing a plurality of obturators, each of said obturators having a first section with a generally cylindrical shape and a threaded hole drilled through its center, a second section having the shape of a conical frustum and having upper and lower diameters, said lower diameter substantially equal to the inner diameter of the base of said bioprosthetic heart valve, a third section having the shape of an inverted conical frustum and having upper and lower diameters, said lower diameter substantially equal to the outer diameter of the base of said bioprosthetic heart valve and a fourth section having a generally cylindrical shape, the diameter of said fourth section being substantially equal to the inflow diameter of said bioprosthetic heart valve, each of said obturators having differing dimensions;

providing a handle having an externally threaded section;

threadably engaging said handle with one of said obturators;

inserting said obturator into the vascular annulus of said patient utilizing said handle;

determining whether said obturator fits within the vascular annulus of said patient;

disengaging and threadably engaging another of said obturators with said handle if said obturator does not fit within the vascular annulus of said patient until a fit is achieved with the vascular annulus of said patient,

said method allowing the quick and accurate determination of the size of the vascular annulus of said patient during replacement of a diseased heart valve in said patient.

6. The method of claim 5, wherein said inserting step further comprises sliding said fourth section of said obturator completely into the annulus of the heart so that said third section of the obturator rests on top of the walls of the annulus.

7. The method of claim 5, wherein said inserting step includes verifying that said annulus is sufficiently free form obstructions.

8. The method of claim 5, wherein said determining step further comprises visually inspecting the fit of said third section of said obturator to the annulus of the heart.

9. The method of claim 5, wherein said disengaging step includes replacing said first obturator with a differently sized second obturator.

10. The method of claim 9, wherein said replacing step further includes utilizing a larger sized obturator for said second obturator if said first obturator is too small.

11. The method of claim 9, wherein said replacing step further includes utilizing a smaller sized obturator for said second obturator if said first obturator is too large.

12. An obturator for measuring the size of an annulus formed in a human heart after a patient'"'"'s valve has been excised, said obturator comprising:

an inverted conical frustum having a first surface having a first diameter and a second surface having a second diameter, said first diameter being larger than said second diameter; and

a generally cylindrical section integral with a portion of the second surface of said inverted conical frustum, the second diameter of the second surface of said inverted conical frustum being larger than a diameter of said generally cylindrical section so that the second surface of said inverted conical frustum rests on the walls of the annulus when said generally cylindrical section is inserted into the annulus.

13. A method for measuring the size of an annulus of a patient'"'"'s valve prior to the implantation of a bioprosthetic heart valve, said method comprising the steps of:

inserting one or more cylinders into the annulus until a cylinder is found having a diameter substantially corresponding to the diameter of the annulus;

pushing said selected cylinder into the annulus until an inverted conical frustum integral with said selected cylinder prevents further ingress of said selected cylinder, said inverted conical frustum having a minimum diameter larger than the diameter of said selected cylinder; and

determining whether any portion of said inverted conical frustum fits within the annulus to thus avoid selecting a valve size which is too small for the patient undergoing surgery.

14. A method for measuring the size of an annulus of a patient'"'"'s valve prior to the implantation of a bioprosthetic heart valve, said method comprising the steps of:

providing a plurality of obturators, each of said obturators having a first section with a generally cylindrical shape and a hole drilled through its center, a second section having the shape of a conical frustum, a third section having the shape of an inverted conical frustum, and a fourth section having a generally cylindrical shape, the fourth section being integral with and smaller in diameter than an adjacent surface of said inverted conical frustum, each of said obturators having differently dimensioned first, second, third and fourth sections;

providing a handle;

engaging said handle with one of said obturators;

inserting said one of said obturators into the annulus using said handle, sequentially repeating said insertion with each remaining of said obturators engaged with said handle until an obturator is found in which its fourth section has a diameter substantially corresponding to the diameter of the annulus;

visually inspecting the first, second and third sections of said selected obturator, corresponding to the bioprosthetic valve configuration; and

determining whether the third section of said selected obturator fits appropriately on the valve annulus so that the appropriately sized valve is selected.

15. A plurality of obturators for measuring the size of a valve annulus in a human heart prior to the implantation of a bioprosthetic replacement heart valve having a base portion with inflow, inner and outer diameters into said heart, each obturator of said plurality being engageable with a handle for insertion into the annulus of said heart, each obturator of said plurality comprising:

a first section having a generally cylindrical shape and a hole drilled through its center;

a second section having the shape of conical frustum;

a third section having the shape of an inverted conical frustum; and

a fourth section having a generally cylindrical shape;

wherein said obturators are manufactured in a plurality of sizes.